Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-26 @ 1:42 PM
Study NCT ID:
NCT00633867
Status:
COMPLETED
Last Update Posted:
2011-08-02
First Post:
2008-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.brampton@nhs.net', 'title': 'W Brampton', 'organization': 'NHS Grampian'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'McGrath', 'description': 'Tracheal Intubation using McGrath video-laryngoscope', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Macintosh', 'description': 'Tracheal intubation using Macintosh Laryngoscope', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'frequencyThreshold': '2.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Difference in Learning to Use the Scopes', 'timeFrame': 'At analysis', 'description': 'Is there a difference between trainee anaesthetists in learning to use the scopes', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of View of the Vocal Cords', 'timeFrame': 'At analysis', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Attempts to Secure Successful Intubation', 'timeFrame': 'At analysis', 'description': 'Is there a difference in the number of attempts required to secure successful intubation ?', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Initial Oesophageal Intubation', 'timeFrame': 'At analysis', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Intubations Taking More Than 70 Seconds', 'timeFrame': 'At Analysis', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Low Arterial Saturation During Intubation', 'timeFrame': 'At analysis', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Visible Trauma to the Airway', 'timeFrame': 'At analysis', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Intubation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'McGrath', 'description': 'Tracheal Intubation using McGrath video-laryngoscope'}, {'id': 'OG001', 'title': 'Macintosh', 'description': 'Tracheal intubation using Macintosh Laryngoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '47.0', 'groupId': 'OG000', 'lowerLimit': '39.0', 'upperLimit': '60.0'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '36.8'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'At intubation', 'description': 'Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'McGrath', 'description': 'Tracheal Intubation using McGrath video-laryngoscope'}, {'id': 'FG001', 'title': 'Macintosh', 'description': 'Tracheal intubation using Macintosh Laryngoscope'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'adult patients undergoing elective tracheal intubation at induction of anaesthesia Between February and August 2008', 'preAssignmentDetails': '139 patients consented for study. 120 assigned to groups. 19 not studied: no McGrath® scope available (n=10). No direct supervision of intubator (n=6). Case cancellation or changes (n=3).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'McGrath', 'description': 'Tracheal Intubation using McGrath video-laryngoscope'}, {'id': 'BG001', 'title': 'Macintosh', 'description': 'Tracheal intubation using Macintosh Laryngoscope'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '63.5'}, {'value': '60.5', 'groupId': 'BG001', 'lowerLimit': '41.3', 'upperLimit': '70'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '66.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-29', 'studyFirstSubmitDate': '2008-03-04', 'resultsFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2008-03-11', 'lastUpdatePostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-25', 'studyFirstPostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation Time', 'timeFrame': 'At intubation', 'description': 'Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation'}], 'secondaryOutcomes': [{'measure': 'Difference in Learning to Use the Scopes', 'timeFrame': 'At analysis', 'description': 'Is there a difference between trainee anaesthetists in learning to use the scopes'}, {'measure': 'Quality of View of the Vocal Cords', 'timeFrame': 'At analysis'}, {'measure': 'Number of Attempts to Secure Successful Intubation', 'timeFrame': 'At analysis', 'description': 'Is there a difference in the number of attempts required to secure successful intubation ?'}, {'measure': 'Incidence of Initial Oesophageal Intubation', 'timeFrame': 'At analysis'}, {'measure': 'Number of Intubations Taking More Than 70 Seconds', 'timeFrame': 'At Analysis'}, {'measure': 'Incidence of Low Arterial Saturation During Intubation', 'timeFrame': 'At analysis'}, {'measure': 'Incidence of Visible Trauma to the Airway', 'timeFrame': 'At analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tracheal intubation', 'Laryngoscopy', 'videolaryngoscope', 'McGrath', 'success', 'time'], 'conditions': ['Tracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '19605408', 'type': 'RESULT', 'citation': 'Walker L, Brampton W, Halai M, Hoy C, Lee E, Scott I, McLernon DJ. Randomized controlled trial of intubation with the McGrath Series 5 videolaryngoscope by inexperienced anaesthetists. Br J Anaesth. 2009 Sep;103(3):440-5. doi: 10.1093/bja/aep191. Epub 2009 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The simplicity of use and intuitive function of the McGrath video-laryngoscope suggests it may have a bigger role than as a back-up to conventional direct laryngoscopy and could possibly be the first-line laryngoscope for situations where difficult intubations are more likely or more hazardous. The incidence of difficult or failed intubation for an individual anaesthetist is related to their experience, decreasing as experience increases. The purpose of this trial is to evaluate the McGrath laryngoscope when used by relatively inexperienced anaesthetists, who are those most likely to encounter difficulties.\n\nThe null hypotheses to be tested is that there is no difference between the Macintosh and McGrath laryngoscope in terms of ease and success in intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years and over) scheduled for elective surgery whose anaesthetic plan would normally include oral intubation using a Macintosh laryngoscope blade after induction of general anaesthesia and who have given valid informed consent.\n\nExclusion Criteria:\n\n* Patients requiring special techniques for intubation such as rapid sequence induction\n* Adults who have learning difficulties\n* Are unconscious or very severely ill\n* Have a terminal illness; are in an emergency situation\n* Have a mental illness\n* Have dementia\n* Prisoners\n* Those who could be considered to have a particularly dependent relationship with the investigator and other vulnerable groups.'}, 'identificationModule': {'nctId': 'NCT00633867', 'briefTitle': 'Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope', 'organization': {'class': 'OTHER_GOV', 'fullName': 'NHS Grampian'}, 'officialTitle': 'Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope', 'orgStudyIdInfo': {'id': '08-so802-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intubation c McGrath videolaryngoscope', 'description': 'Tracheal Intubation using McGrath video-laryngoscope', 'interventionNames': ['Device: McGrath']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intubation using Macintosh Laryngoscope', 'description': 'Tracheal intubation using Macintosh Laryngoscope', 'interventionNames': ['Device: Tracheal intubation using Macintosh Laryngoscope']}], 'interventions': [{'name': 'McGrath', 'type': 'DEVICE', 'otherNames': ['Aircraft Medical McGrath Series 5 Video Laryngoscope'], 'description': 'Tracheal intubation, using Mcgrath video-laryngoscope', 'armGroupLabels': ['Intubation c McGrath videolaryngoscope']}, {'name': 'Tracheal intubation using Macintosh Laryngoscope', 'type': 'DEVICE', 'description': 'Tracheal intubation using Macintosh Laryngoscope', 'armGroupLabels': ['Intubation using Macintosh Laryngoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'UK', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Hospitals, NHS Grampian', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}], 'overallOfficials': [{'name': 'william brampton', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Grampian'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Grampian', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Doctor William Brampton', 'oldOrganization': 'NHS Grampian'}}}}